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Healthcare Professional Interviews: Data Disclosures in Communications About Prescription Drugs
Data to Support Drug Product Communications
OMB: 0910-0695
IC ID: 238253
OMB.report
HHS/FDA
OMB 0910-0695
ICR 201712-0910-001
IC 238253
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:
2024-03-07 - Extension without change of a currently approved collection
2022-06-30 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
Appendix A-Email_Screener_Invitation Oncologists.docx
Other-Email, Screener, and Invitatio
Appendix B-Email_Screener_Invitation PCPs.docx
Other-Email, Screener, and Invitatio
Appendix C - Confirmation Email Letter.docx
Other-Confirmation email
Appendix D - Informed Consent.docx
Other-Informed Consents
Appendix E - Reminder Email.docx
Other-Reminder email
Appendix F - Remote Interview Guide.docx
Other-Interview Guide
0695 OMB Approval Memo-Data Disclosures 2019.docx
OMB Approval Memo
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Healthcare Professional Interviews: Data Disclosures in Communications About Prescription Drugs
Agency IC Tracking Number:
CDER
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Email, Screener, and Invitation for Oncologists
Appendix A-Email_Screener_Invitation Oncologists.docx
Yes
Yes
Fillable Fileable
Other-Email, Screener, and Invitation for PCPs
Appendix B-Email_Screener_Invitation PCPs.docx
Yes
Yes
Fillable Fileable
Other-Confirmation email
Appendix C - Confirmation Email Letter.docx
Yes
Yes
Printable Only
Other-Informed Consents
Appendix D - Informed Consent.docx
Yes
Yes
Fillable Fileable
Other-Reminder email
Appendix E - Reminder Email.docx
Yes
Yes
Printable Only
Other-Interview Guide
Appendix F - Remote Interview Guide.docx
Yes
No
Printable Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
140
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
140
0
140
0
0
0
Annual IC Time Burden (Hours)
87
0
87
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
OMB Approval Memo
0695 OMB Approval Memo-Data Disclosures 2019.docx
10/23/2019
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.